Colorectal Cancer
Conditions
Brief summary
This study evaluates the relationship of biomarker expression and efficacy of bevacizumab plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3 expression in tumor tissue by IHC and detect those protein expression level in plasma by ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D expression level in plasma by ELISA. The aim of the study is to identify whether those biomarkers could predict Bevacizumab efficacy.
Interventions
DRUGOxaliplatin
DRUGXeloda
DRUGCalcium folinate (CF)
DRUG5-FU
DRUGBevacizumab
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* More than 18-years old,male or female * Pathologically approved as unresectable/metastatic colorectal cancer * KPS \> 70% or ECOG 0-2 * HGB \> 80 g/L, NEUT ≥ 1.5x109 /L, PLT ≥ 80x109 /L; CR \< 1.5 x Upper normality， * TB \< 1.5 X Upper normality，AST or ALT \< 2.5 x Upper normality. * Signed consent
Exclusion criteria
* Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer * Pregnancy or in lactation * HGB \< 80 g/L, NEUT \< 1.5x109 /L, PLT \< 80x109 /L; CR ≥ 1.5 x Upper normality， TB ≥ 2.5 X Upper normality，AST or ALT ≥2.5 x Upper normality，AKP ≥ 2.5 X Upper normality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 36 months | During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 36 months | The start time point was defined as when patients receive the first cycle chemotherapy.The end time point was defined as When tumor response to therapy was evaluated as PD according to RECIST 1.1 or patients die for any reason. |
| overall survival | 36 months | From the time patients receive the first cycle chemotherapy to the time they die for any reason. |
| Number of Participants with Adverse Events | 36 months | Every cycle we demonstrate routine blood test,routine urine test,routine stool test,blood biochemical test.We recommend patients take blood pressure at least twice a week during the therapy.If needed,patients also need have electrocardiogram test and echocardiography.We will evaluate the toxicity according to CTCAE4.0 |
Countries
China
Outcome results
None listed